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FDA Drug information

Carbamazepine ER

Read time: 1 mins
Marketing start date: 19 Feb 2025

Summary of product characteristics


Adverse Reactions

ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING ), the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Skin : Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING ), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary. Cardiovascular System : Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds. Liver : Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure. Pancreatic: Pancreatitis. Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia. Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal spermatogenesis. Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown. Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome. There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs. Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis. Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General ) as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes. Musculoskeletal System: Aching joints and muscles, and leg cramps. Metabolism: Fever and chills. Hyponatremia (see WARNINGS, General ). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported. Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants. A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Contraindications

CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.

Description

DESCRIPTION Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5H-dibenz [b, f] azepine-5-carboxamide, and its structural formula is: Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients : cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. FDA approved dissolution test specifications differ from USP. "Image Description"

Dosage And Administration

DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions ). Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents. Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests ). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon four times a day and to increase slowly to avoid unwanted side effects. Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension). Carbamazepine extended-release tablets are an extended-release formulation for twice a day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered. Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets, or tablets without a release portal, should not be consumed. Carbamazepine extended-release tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.

Indications And Usage

INDICATIONS AND USAGE

Warnings

WARNINGS

Drug Abuse And Dependence

DRUG ABUSE AND DEPENDENCE No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

Overdosage

OVERDOSAGE

Clinical Pharmacology

CLINICAL PHARMACOLOGY In controlled clinical trials, carbamazepine has been shown to be effective in the treatment of psychomotor and grand mal seizures, as well as trigeminal neuralgia.

Effective Time

20241113

Version

1

Spl Product Data Elements

Carbamazepine ER Carbamazepine ER MAGNESIUM STEARATE BROWN IRON OXIDE TITANIUM DIOXIDE MANNITOL TALC DEXTRATES POLYETHYLENE GLYCOL 8000 POWDERED CELLULOSE SODIUM LAURETH SULFATE CARBAMAZEPINE CARBAMAZEPINE CER;100 Carbamazepine ER Carbamazepine ER MAGNESIUM STEARATE BROWN IRON OXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE MANNITOL DEXTRATES POLYETHYLENE GLYCOL 8000 POWDERED CELLULOSE CARBAMAZEPINE CARBAMAZEPINE CER;200 Carbamazepine ER Carbamazepine ER MAGNESIUM STEARATE BROWN IRON OXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE MANNITOL DEXTRATES POLYETHYLENE GLYCOL 8000 POWDERED CELLULOSE CARBAMAZEPINE CARBAMAZEPINE CER;400

Application Number

ANDA215591

Brand Name

Carbamazepine ER

Generic Name

Carbamazepine ER

Product Ndc

62135-928

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL Carbamazepine Extended-Release Tablets, USP 100 mg - NDC 62135-927-60 60s Bottle Label Carbamazepine Extended-Release Tablets, USP 200 mg - NDC 62135-928-60 60s Bottle Label Carbamazepine Extended-Release Tablets, USP 400 mg - NDC 62135-930-60 60s Bottle Label "Image Description" "Image Description" "Image Description"

Spl Unclassified Section

Before prescribing carbamazepine, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.

Spl Unclassified Section Table

Indication

Placebo Patients with Events Per 1,000 Patients

Drug Patients with Events Per 1,000 Patients

Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients

Risk Difference: Additional Drug Patients with Events Per 1,000 Patients

Epilepsy

1.0

3.4

3.5

2.4

Psychiatric

5.7

8.5

1.5

2.9

Other

1.0

1.8

1.9

0.9

Total

2.4

4.3

1.8

1.9

Spl Medguide

Print Medication Guides at: www.chartwellpharma.com/medguides. MEDICATION GUIDE Carbamazepine (kar" ba maz' e peen) Extended-Release Tablets, USP Read this Medication Guide before you start taking carbamazepine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about carbamazepine extended-release tablets? Do not stop taking carbamazepine extended-release tablets without first talking to your healthcare provider. Stopping carbamazepine extended-release tablets suddenly can cause serious problems. Carbamazepine extended-release tablets can cause serious side effects, including: 1. Carbamazepine extended-release tablets may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine extended-release tablets within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine extended-release tablets to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include: skin rash hives sores in your mouth blistering or peeling of the skin 2. Carbamazepine extended-release tablets may cause rare but serious blood problems. Symptoms may include: fever, sore throat, or other infections that come and go or do not go away easy bruising red or purple spots on your body bleeding gums or nose bleeds severe fatigue or weakness 3. Carbamazepine extended-release tablets may cause allergic reactions or serious problems, which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: swelling of your face, eyes, lips, or tongue a skin rash painful sores in the mouth or around your eyes unusual bruising or bleeding frequent infections or infections that do not go away fever, swollen glands, or sore throat that do not go away or come and go trouble swallowing or breathing hives yellowing of your skin or eyes severe fatigue or weakness severe muscle pain 4. Like other antiepileptic drugs, carbamazepine extended-release tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop carbamazepine extended-release tablets without first talking to a healthcare provider. Stopping carbamazepine extended-release tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What are carbamazepine extended-release tablets? Carbamazepine extended-release tablets are a prescription medicine used to treat: certain types of seizures (partial, tonic-clonic, mixed) certain types of nerve pain (trigeminal and glossopharyngeal neuralgia) Carbamazepine extended-release tablets are not a regular pain medicine and should not be used for aches or pains. Who should not take carbamazepine extended-release tablets? Do not take carbamazepine extended-release tablets if you: have a history of bone marrow depression. are allergic to carbamazepine or any of the ingredients in carbamazepine extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in carbamazepine extended-release tablets. take nefazodone. are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. What should I tell my healthcare provider before taking carbamazepine extended-release tablets? Before you take carbamazepine extended-release tablets, tell your healthcare provider if you: have or have had suicidal thoughts or actions, depression, or mood problems have or ever had heart problems have or ever had blood problems have or ever had liver problems have or ever had kidney problems have or ever had allergic reactions to medicines have or ever had increased pressure in your eye have any other medical conditions drink grapefruit juice or eat grapefruit use birth control. Carbamazepine extended-release tablets may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and carbamazepine. are pregnant or plan to become pregnant. Carbamazepine may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking carbamazepine extended-release tablets. You and your healthcare provider should decide if you should take carbamazepine extended-release tablets while you are pregnant. If you become pregnant while taking carbamazepine extended-release tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take carbamazepine extended-release tablets or breastfeed; you should not do both. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking carbamazepine extended-release tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take carbamazepine extended-release tablets? Do not stop taking carbamazepine extended-release tablets without first talking to your healthcare provider. Stopping carbamazepine extended-release tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus). Take carbamazepine extended-release tablets exactly as prescribed. Your healthcare provider will tell you how many carbamazepine extended-release tablets to take. Your healthcare provider may change your dose. Do not change your dose of carbamazepine extended-release tablets without talking to your healthcare provider. Take carbamazepine extended-release tablets with food. Carbamazepine extended-release tablets: . Do not crush, chew, or break carbamazepine extended-release tablets. Tell your healthcare provider if you can not swallow carbamazepine extended-release tablets whole. If you take too many carbamazepine extended-release tablets, call your healthcare provider or local Poison Control Center right away. What should I avoid while taking carbamazepine extended-release tablets? Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine extended-release tablets until you talk to your healthcare provider. Carbamazepine extended-release tablets taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery, or do other dangerous activities until you know how carbamazepine extended-release tablets affects you. Carbamazepine extended-release tablets may slow your thinking and motor skills. What are the possible side effects of carbamazepine extended-release tablets? See “What is the most important information I should know about carbamazepine extended-release tablets?” Carbamazepine extended-release tablets may cause other serious side effects. These include: Irregular heartbeat-symptoms include: Fast, slow, or pounding heartbeat hortness of breath Feeling lightheaded Fainting Liver problems -symptoms include: yellowing of your skin or the whites of your eyes dark urine pain on the right side of your stomach area (abdominal pain) easy bruising loss of appetite nausea or vomiting Get medical help right away if you have any of the symptoms listed above or listed in “What is the most important information I should know about carbamazepine extended-release tablets?” The most common side effects of carbamazepine extended-release tablets include: dizziness drowsiness problems with walking and coordination (unsteadiness) nausea vomiting These are not all the possible side effects of carbamazepine extended-release tablets. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088. How should I store carbamazepine extended-release tablets? Store carbamazepine extended-release tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep carbamazepine extended-release tablets dry. Keep carbamazepine extended-release tablets and all medicines out of the reach of children. General Information about carbamazepine extended-release tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use carbamazepine extended-release tablets for a condition for which it was not prescribed. Do not give carbamazepine extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about carbamazepine extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about carbamazepine extended-release tablets that is written for health professionals. For more information call 1-845-232-1683. What are the ingredients in carbamazepine extended-release tablets? Active ingredient: carbamazepine Inactive ingredients: Cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L72448 Revised: 11/2024

How Supplied

HOW SUPPLIED Carbamazepine Extended-release tablets, USP 100 mg -round, yellow, coated (imprinted CER 100 on one side), release portal on one side Bottles of 60 ........................................................................................................ NDC 62135-927-60 Carbamazepine Extended-release tablets, USP 200 mg -round, yellow, coated (imprinted CER 200 on one side), release portal on one side Bottles of 60 ........................................................................................................ NDC 62135-928-60 C arbamazepine Extended-release tablets, USP 400 mg - round, yellow, coated (imprinted CER 400 on one side), release portal on one side Bottles of 60 ........................................................................................................ NDC 62135-930-60 Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). * Thorazine ® is a registered trademark of GlaxoSmithKline. Manufactured by: Bostal Drug Delivery Co., Ltd. 6F, Building C2, No.11 Kaiyuan Road, Guangzhou Science Park, Guangzhou High-tech Industrial Development Zones, Guangzhou, Guangdong 510530, China (CHN) Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L72447 Rev: 11/2024 All Product/Brand names are the trademarks of their respective owners. Print Medication Guides at: www.chartwellpharma.com/medguides.

Boxed Warning

WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH CARBAMAZEPINE UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS , LABORATORY TESTS ). APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA. ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS. BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS

Precautions

PRECAUTIONS

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